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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ENCORE MEDICAL L.P. TURON SHOULDER; TURON PEGGED GLENOID, SZ 42MM, EPLUS
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ENCORE MEDICAL L.P. TURON SHOULDER; TURON PEGGED GLENOID, SZ 42MM, EPLUS Back to Search Results
Catalog Number 521-01-242
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/06/2017
Type of Reportable Event Serious Injury
Event or Problem Description
Revision surgery -the patient was not complaint and did not wear a sling after the primary surgery; the patient had a failed sub-scapular.
 
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this revision surgery was a failed subscapularis.The in-vivo length of patient service for the implant was 4.3 months.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for this event was the patient was not compliant with post operation requirements and did not use a sling.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
 
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Brand Name
TURON SHOULDER
Common Device Name
TURON PEGGED GLENOID, SZ 42MM, EPLUS
Manufacturer (Section D)
ENCORE MEDICAL L.P.
9800 metric blvd.
austin TX 78758 5445
MDR Report Key6386087
Report Number1644408-2017-00125
Device Sequence Number943500
Product Code KWS
UDI-Device Identifier00888912024884
UDI-Public(01)00888912024884
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
K123982
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date12/23/2020
Device Catalogue Number521-01-242
Device Lot Number799N1039
Was Device Available for Evaluation? No
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 02/06/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date03/07/2017
Supplement Report FDA Received Date04/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
520-01-008,LOT 454G1110; 520-46-116,LOT 923C1111; 521-01-242,LOT 799N1039
Outcome Attributed to Adverse Event Required Intervention;
Patient Age65 YR
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